The purpose of this study is to determine whether CARTISTEM, a cell therapeutic product, is safe and effective in the treatment of articular cartilage defects of the knee as a result of ageing, trauma, or degenerative diseases.

Conventional treatment modalities have not been able to provide complete and sustained resolution of symptoms following damage to the articular cartilage. Despite the numerous techniques available today, complete healing of damaged or defective cartilage or consistent reproduction of normal hyaline cartilage does not occur, and continuous drug administration or secondary surgeries are common.

Research in mesenchymal stem cells has had a rapid acceleration over the past decade and MSC-based therapy has become one of the objects of investigation for a new branch of medicine termed regenerative medicine. This emerging technology shows great promise for producing transplantable cartilage constructs to restore the function of degenerated joints.

CARTISTEM®, a combination of human umbilical cord blood-derived mesenchymal stem cells and sodium hyaluronate, is intended to be used as a single-dose cellular therapeutic agent for cartilage regeneration in human subjects with cartilage defects of the knee as a result of ageing, trauma, or degenerative diseases.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients with an intended- to- treat single focal, full-thickness cartilage defect (ICRS [International Cartilage Repair Society] Grade 3 or 4) of the knee as a result of ageing, trauma, or degenerative diseases.

Age ≥ 18 years old

Size of the articular cartilage lesion is ≥ 2 cm2

Swelling, tenderness and active range of motion ≤ Grade II

Joint pain : 20-mm - 60-mm on VAS (Visual Analog Scale) at the time of Screening

No meniscal surgery within the past 3 months and more than 5mm of meniscal rim remaining

Ability and willingness to fully participate in the post-operative rehabilitation program

Subject is informed of the investigational nature of this study, voluntarily agrees to participate in the study, and signs an IRBapproved informed consent prior to performing any of the screening procedures

Body Mass Index (BMI) ≤ 35 kg/m2

Exclusion Criteria:

Patients who have been treated previously and are asymptomatic

Avascular necrosis/ osteonecrosis

Autoimmune or inflammatory joint disease

History of infection within the past 6 weeks

Surgery or radiation therapy within the past 6 weeks

Serious medical co-morbidities, which would otherwise contraindicate surgery, as determined by the investigator

Currently pregnant or nursing

Psychotic diseases, epilepsy, or any history of such diseases

Current abuse of alcohol (> 10 drinks weekly) and/or regular exposure to other substances of abuse, currently an active smoker

Chronic inflammatory articular diseases such as rheumatoid arthritis

Enrolled in any other clinical trials within the past 4 weeks

Administered immunosuppressants such as Cyclosporin A or azathioprine within the past 6 weeks

Corticosteroid or viscosupplementation injection to the affected knee in the past 3 months

Principal investigator considers inappropriate for the clinical trial due to any reasons other than those listed above

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733186